Personalized Feedback for Cancer Survivor Physical Activity

(Project KNOWN Trial)

Overseen By Yue Liao, MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Must not be taking: Oral antidiabetics, Insulin

Disqualifiers: Pregnancy, Dialysis, Low-carb diet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether personalized feedback can motivate cancer survivors to increase their activity levels, potentially benefiting those at high risk for type 2 diabetes. Participants will use wearable technology to see real-time effects of exercise on their blood sugar, which might encourage more frequent exercise. The trial compares two groups: one receiving glucose-based biofeedback (using blood sugar levels for feedback) and another receiving standard feedback. Ideal candidates are cancer survivors who have completed treatment, do not have diabetes, and are not very active. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could promote healthier lifestyles for cancer survivors.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking oral antidiabetic agents or any insulin regimen other than basal insulin. If you are on these medications, you would need to stop them to participate.

What prior data suggests that this personalized feedback strategy is safe for cancer survivors?

A previous study found glucose-based biofeedback to be generally safe and practical for cancer survivors. This method uses a device to continuously monitor blood sugar levels and provides personalized feedback on physical activity. Research shows that cancer survivors find this feedback helpful and motivating for increasing their activity levels. No major safety issues have been reported, making this a promising option for those who want to safely increase their daily exercise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Feedback for Cancer Survivor Physical Activity trial because it explores a unique approach to boosting physical activity among cancer survivors. Unlike traditional methods that rely on general advice or standard feedback, this trial uses glucose-based biofeedback to deliver personalized insights. By tracking glucose levels and providing real-time feedback, the hope is to encourage more effective and tailored exercise regimens that can significantly improve health outcomes for cancer survivors. This personalized approach could lead to more engaging and motivating fitness plans, potentially enhancing the quality of life in this special population.

What evidence suggests that this trial's treatments could be effective for promoting physical activity in cancer survivors?

Research has shown that glucose-based biofeedback, provided to participants in the Biofeedback Group of this trial, can help cancer survivors become more active. One study demonstrated that a device offering this feedback increased daily activity by 21% among 19 cancer patients. This method uses continuous glucose monitoring to display real-time effects of exercise on blood sugar levels. Observing these immediate changes can motivate increased exercise. Overall, these findings suggest glucose-based biofeedback could effectively encourage more exercise among cancer survivors at risk for type 2 diabetes. Meanwhile, participants in the Standard Care Group will receive standard feedback as part of this trial. ^{1 2 3 4 6}

Who Is on the Research Team?

Yue Liao, MPH, PhD

Principal Investigator

University of Texas at Arlington

Are You a Good Fit for This Trial?

This trial is for cancer survivors over 18, who've finished treatment at least 3 months ago and are at high risk for type 2 diabetes due to inactivity. Participants must speak English, have a smartphone with internet, and be able to exercise moderately without supervision. Those on certain insulin treatments, other health programs, incompatible smartphones, pregnant women, dialysis patients, overnight workers or those with activity-limiting health issues can't join.

Inclusion Criteria

I can do moderate to hard exercise on my own.

Able to speak, read, and write in English

Have a smartphone with daily internet access

Exclusion Criteria

I do not own a smartphone that works with Fitbit and LibreLink apps.

Currently pregnant

I am currently on dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week physical activity intervention with personalized biological feedback

12 weeks

Follow-up

Participants are monitored for changes in physical activity levels and glucose patterns

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glucose-based biofeedback
• Glucose monitoring
• Standard feedback

Trial Overview The study tests if real-time glucose feedback from wearable devices motivates physical activity in inactive cancer survivors at risk of type 2 diabetes. It compares standard feedback against glucose-based biofeedback using continuous monitors and tracks daily activity levels to see the immediate effects of exercise on biological status.

How Is the Trial Designed?

Group I: Biofeedback Group Experimental Treatment 1 Intervention

Group II: Standard Care Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Published Research Related to This Trial

Wearable activity monitors, like ActiGraph accelerometers and Fitbits, are generally accepted and effective tools for increasing physical activity levels among cancer survivors, as shown in a review of 28 studies involving both active treatment and post-treatment individuals.

While these devices successfully motivate short-term increases in physical activity, the benefits tend to decrease over time, highlighting the need for further research to enhance the long-term sustainability of these technologies in supporting ongoing physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. Keats, MR., Yu, X., Sweeney Magee, M., et al.[2023]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

Breast cancer patients using a wearable activity tracker (WAT) along with counseling showed a significant increase in leisure-time physical activity (LTPA) during radiation therapy, with a relative change of 102.8 compared to 57.8 in the counseling-only group.

The WAT+counseling group also had a notable increase in average daily step counts from 9351.7 to 12,240.1 during and after radiation therapy, indicating that the combination of WAT and counseling is effective in promoting physical activity among these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Effectiveness of a Wearable Activity Tracker in Addition to Counseling and Counseling Only to Reinforce Leisure-Time Physical Activity among Breast Cancer Patients: A Randomized Controlled Trial. Kong, S., Lee, JK., Kang, D., et al.[2021]

A 12-week supervised aerobic exercise program for 15 postmenopausal breast cancer survivors led to significant improvements in fitness and body composition, with participants averaging 156.8 minutes of exercise per week.

While exercise did not significantly change overall insulin resistance measures, it did result in lower insulin levels 120 minutes after glucose consumption, and this effect was notably influenced by the use of aromatase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metrics of Diabetes Risk Are Only Minimally Improved by Exercise Training in Postmenopausal Breast Cancer Survivors. Viskochil, R., Blankenship, JM., Makari-Judson, G., et al.[2021]

A biofeedback device significantly improved physical activity levels in 19 cancer patients, increasing their daily activity counts by 21% and moderate to vigorous physical activity by 9% after receiving real-time visual feedback.

After using the biofeedback device, the physical activity levels of cancer patients became nearly equal to those of 20 age-matched healthy controls, indicating the device's effectiveness in promoting activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time visual activity feedback for physical activity improvement in breast and colon cancer patients. Gabrys, L., Sperzel, S., Bernhoerster, M., et al.[2019]

A pilot study will assess the effectiveness of a 12-week physical activity intervention using personalized feedback from continuous glucose monitors (CGMs) to motivate cancer survivors, particularly those at high risk for type 2 diabetes (T2D).

The study aims to explore how daily glucose patterns relate to cancer-related insulin pathways and inflammation, potentially providing insights into the biological mechanisms by which physical activity can benefit cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN). Liao, Y., Schembre, SM., Brannon, GE., et al.[2022]

A study of 464 breast cancer survivors found that personal control significantly influences their levels of physical activity after treatment, highlighting the importance of self-efficacy in recovery.

The impact of treatment-related factors and psychological well-being on physical activity varied based on whether the women were working or not, suggesting that tailored interventions should consider individual circumstances and symptoms like fatigue and body image.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-related and psychosocial variables in explaining physical activity in women three weeks to six months post-treatment of breast cancer. Charlier, C., Van Hoof, E., Pauwels, E., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12304624/

Using Continuous Glucose Monitoring as a Biological ... This study used a mixed-methods approach to test the acceptability and changes in physical activity motivation of a pilot intervention that ...

2. withpower.com withpower.com/trial/phase-malignancies-8-2022-f7c3d

Personalized Feedback for Cancer Survivor Physical Activity A biofeedback device significantly improved physical activity levels in 19 cancer patients, increasing their daily activity counts by 21% and moderate to ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0274492

Study protocol for a randomized controlled physical activity ... Therefore, we propose to use glucose data as the basis for providing such biofeedback in cancer survivors to motivate physical activity for two ...

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/20552076221129096

A qualitative study to explore the acceptability and ... Glucose-based biofeedback provides relevant and motivating information for cancer survivors regarding their daily activity levels by ...

5. researchgate.net researchgate.net/publication/361425423_The_use_of_glucose-based_biofeedback_to_motivate_physical_activity_in_cancer_survivors_A_pilot_intervention_study

The use of glucose-based biofeedback to motivate physical ... The use of glucose-based biofeedback to motivate physical activity in cancer survivors: A pilot intervention study. April 2022. Conference: 43rd Annual ...

6. aicr.org aicr.org/research/projects/personalized-feedback-of-wearable-biological-sensor-data-to-promote-active-living-in-cancer-survivors/

Personalized feedback of wearable biological sensor data ... This study aims to promote daily physical activity in cancer survivors who are at high risk for type 2 diabetes (T2D) by using a personalized biological-based ...